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Sometimes, better than giving advice about how to run things well, it can be useful to have a hit list to notice to help you identify when things are less than productive.

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

Meetings can be hugely productive, especially if you keep a sharp eye out for these Ten things:-

No Agenda

When there is no agenda, there is no oppo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

rtunity to prepare, no framework for the meeting and no purpose. When this happens a lot, there is a tendency for 5 below.

Wrong people there

Ever been to a m

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

eeting where there was no logical purpose for you to be there? Meeting time is valuable and it is important for efficiency and effectiveness that as few people attend as p

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rposeful. People should appreciate that non-attendance at a particular meeting is OK and get used to it.

Overrun

Those times when you sit in a meeting and wat

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ch your life slip away, are those that happened with poor meeting management. There is nothing worse than unkept promises (and meetings are just that - a contract to the p

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

articipants time) and must be honoured. Everyone has a role here.

Indiscipline

Many meeting participants do not know how to behave. These are things about th

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

em and their ego, lack of self-confidence and poor behaviours (out side the meeting too). Lack of courtesy, understanding and space for others to say their piece is inexcu

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

able and not constructive for the outcome

The Leader Leads

Here the meeting is at the beck and call of the leader or chair who really is holding court for them

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

selves. This sort of meeting is about them showing that they are democratic, but they are nothing of the sort. This is a rubber-stamping meeting and is of little or no va

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

lue

The Leader Doesn't Lead

Here there is free-for-all, with no leadership from the chair. Poor behaviours, timekeeping and outcomes riddle this sort of meeti

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ng, with and end no-result and frayed-tempered, frustrated people

Environment

Too hot, too cold, no water, no breaks, too big, too small. Have you ever been i

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

one of those meetings? And aren't they awful, so awful in fact that you can't do your best. This is a meeting where the organisers do not respect the participants

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

B>Nothing Happens

A lovely chat, a few disagreements and 'see you next month'. This is the nice-to-have meeting which does nothing and goes nowhere. As Peter Drucker

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

said, 'Meetings are a symptom of bad organization. The fewer meetings the better'

Side-tracked/New Stuff

With an agenda, people know what the meeting will be a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

bout - or will they. Even with the best agenda'd meeting weak processes tend to leave to new issues, side-tracking and wasted time. This is solvable with effort from the

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

acilitator

No Review and Growth

Meetings come and go and are always awful. They are unproductive, boring, overrun and people are there who shouldn't be. If th

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ere is no review of just how good or bad the meeting has been, there will be no improvement. The leader/facilitator can add in meeting feedback as the first agenda item an

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

d stick to it - tough at first but gets easier.

Step by step, you can work, with a facilitator or not, to unravel just what needs to change. You will make a big diffe

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

rence, not only to meetings and how productive they are, but also to your capacity to build great relationships with the people who show up.

That's Leadership

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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